Regional Drug Substance Project Lead

Fraser Dove International; New Jersey; On-site; USD 150,000 - 210,000; Full time

Job summary

Fraser Dove International seeks a Regional Project Head, US to lead the Drug Substance capital project portfolio across its US manufacturing network. The role requires delivering complex greenfield and brownfield facilities on time and within budget, with strong contractor management and CQV alignment.

You will drive fast-track schedules, manage EPC/EPCM contractors and ensure compliance with cGMP and FDA expectations, while mentoring project teams to achieve global engineering standards and

Qualifications

• 10+ years of capital project leadership in pharma/biotech/CDMO industries.
• Experience delivering greenfield and brownfield Drug Substance projects.
• Knowledge of cGMP, FDA expectations, and US building codes.
• Strong matrix leadership and contractor management experience.
• Experience with CQV and regulatory inspections (FDA PAIs).

Responsibilities

• Lead greenfield and brownfield Drug Substance capital projects across US sites.
• Drive fast-track schedules, project controls, budget tracking and stage-gate governance.
• Manage EPC/EPCM contractors, permitting processes and delivery teams.
• Oversee Drug Substance infrastructure including biologics and small molecule facilities, cleanrooms and utilities.
• Direct and mentor site Project Managers to align with global standards and stage-gate processes.
• Resolve supply-chain constraints and design changes with risk-based engineering decisions.
• Partner with QA, Regulatory and Commercial Ops to ensure assets are commissioned for FDA PAIs and technology transfers.

Skills

Capital project leadership

CDMO industry experience

US market experience

Vendor/Contractor management

Regulatory/compliance knowledge

Education

Bachelor’s degree in Chemical Engineering or related engineering

Master’s degree in Chemical Engineering or related engineering

Job description

Fraser Dove International seeks a Regional Project Head, US to lead the Drug Substance capital project portfolio across its US manufacturing network. The role requires delivering complex greenfield and brownfield facilities on time and within budget, with strong contractor management and CQV alignment.

You will drive fast-track schedules, manage EPC/EPCM contractors and ensure compliance with cGMP and FDA expectations, while mentoring project teams to achieve global engineering standards and